MAUDE Adverse Event Report: PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE

Model Number SSNF

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/31/2019

Event Type  malfunction  

Manufacturer Narrative

A procedure was performed using the safesept needle free (ssnf).When removing the wire from the introducer, it was noticed that the distal "j" portion of the wire was missing.The device history was reviewed and found no anomalies.Proper materials and methods of manufacturing were utilized.The unit was not returned for analysis.If additional information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the user was unable to cross the septum.The wire was removed from the cannula, and it was noticed that the distal end was missing.

• Brand Name: SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE
• Type of Device: NEEDLE FREE TRANSSEPTAL GUIDEWIRE
• Manufacturer (Section D): PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC; 1 school street; morton PA 19070
• Manufacturer (Section G): PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC; 1 school street; morton PA 19070
• Manufacturer Contact: andrew armour ; 1 school street; morton, PA 19070 ; 6102859858
• MDR Report Key: 9644694
• MDR Text Key: 198729185
• Report Number: 3013986346-2020-00001
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00858769006111
• UDI-Public: (01)00858769006111(17)240801(11)190807(10)000625
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SSNF
• Device Catalogue Number: SSNF
• Device Lot Number: 000625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1